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ella, a morning after drug made by French drug maker HRA Pharma, presents a host of safety concerns for women and that clinical trials haven’t begun to fully evaluate potential medical problems.
The Food and Drug Administration is clearing the way for a new abortion drug called ella (also known as ellaOne and ulipristal) to be approved and used as a new ‘morning after pill’ to prevent pregnancy.
According to the FDA, ella, made by French drug maker HRA Pharma, appears to work with no unexpected side effects however the American Association of Pro Life Obstetricians & Gynecologists and Americans United for Life disagree. Both groups have filed papers with the FDA asking the agency not to approve the drug for over the counter sales.
The documents show that ella or ulipristal acts as an abortion drug.
Anna Glasier, of NHS Lothian in Edinburgh, led a study of more than 5,500 women in the UK published online in The Lancet medical journal. It found fewer pregnancies among those women given the ellaOne drug within five days of intercourse.
And for women who took the drug between 3-5 days after having sex, only women taking the traditional morning after pill became pregnant. That’s because all of the women using ulipristal during that time period had abortions.
“AAPLOG has concluded from publicly available information that ulipristal acetate is an abortifacient of the same type as mifepristone (RU 486) and that its approval as an emergency contraceptive raises serious health and ethical issues,” the letter says. “Furthermore, ulipristal’s potential effects on women who used the drug off-label and upon ongoing pregnancies are essentially unexamined and untested.”
The medical literature, AAPLOG says, has established that ellaOne has the “ability to destroy established pregnancies, as well as prevent implantation.”
The FDA review papers say the makers of the drug have shown it has no unexpected side effects, though normal side effects such as nausea, headache and abdominal pain were common.
AAPLOG noted the drug presents a host of safety concerns for women and that clinical trials haven’t begun to fully evaluate potential medical problems. “The adverse events reported during the clinical trials include a profile of increased infections and bleeding disturbances not surprisingly similar to the adverse events reported for mifepristone,” the doctors wrote. “The increase in infections is predictable ... Yet even more disturbing are the reports of ovarian pain (common) and ovarian cyst formation in clinical trial participants. In three patients the cyst formation did not resolve; which resulted in two cases of surgery: one exploratory surgery for ruptured cysts and one surgical removal of an ovary.”
